BurnPhase 2NCT07025408
Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns
A Phase 2 study testing KJ101 and Chymotrypsin in people with Burn and Burn Wounds - Partial Thickness (2nd Degree), run by Shanghai Bao Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled Phase II clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of KJ101 for the debridement of deep second-degree burns. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn, Burn Wounds - Partial Thickness (2nd Degree)
- What is being tested?
- KJ101 and Chymotrypsin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2025to 29 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18 to 65 years inclusive, who are neither pregnant nor lactating;
- Clinically diagnosed with superficial or deep II degree burns within 72 hours of injury, with a total burn area of ≤30% TBSA. The target burn wound must be isolated or have distinguishable boundaries, with an area between 40 and 200 cm².
- Subjects of childbearing age must agree to use effective and safe contraceptive methods during the treatment period and for three months after the final administration.
Who cannot join
- Individuals who are known to be allergic to any component of the test drug or who have a tendency to allergies.
- Burns caused by specific factors, such as electrical or chemical burns.
- Subjects with shock or inhalation lung injury;
- Subjects with target wounds complicated by inflammatory skin diseases (e.g. atopic dermatitis, eczema or psoriasis), or who have undergone enzymatic debridement (e.g. with collagenase, papain, bromelain, chymotrypsin or trypsin).
- Subjects who, during screening, are judged by the investigator to have other severe systemic infections requiring systemic treatment;
- Abnormal liver or kidney function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Yan Liu, 0086-021-34186000, rjliuyan@126.com
Yan Liu, MD
About this study
Official title: A Multicentre, Randomised, Double-blind, Dose-exploratory, Controlled Drug and Placebo-controlled Phase II Clinical Trial Evaluating the Safety, Efficacy, Pharmacokinetic Profile, and Immunogenicity of KJ101 for Wound Debridement in Deep II Degree Burns
This multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled Phase II clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of KJ101 for the debridement of deep second-degree burns. The trial will provide supporting evidence for subsequent Phase III trials.
Read the detailed description
This multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled Phase II clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of KJ101 in the debridement of deep second-degree burns. The aim is to provide supporting evidence for subsequent Phase III clinical trial.
The study comprises four treatment groups: KJ101 at a dose of 800 U/mL; KJ101 at a dose of 1200 U/mL; an active comparator group receiving chymotrypsin at a dose of 800 U/mL; and a placebo control group.
Approximately 144 screened and qualified subjects will be randomised at a ratio of 1:1:1:1 to one of the four groups. All interventions will be administered locally to the target wound at the following frequencies: once daily prior to complete necrotic tissue debridement, and then every other day post-debridement.
Treatment will continue until complete wound healing is achieved (with a maximum treatment duration of 28 days), after which there will be a one-week safety follow-up period will be conducted.
- Conditions
- Burn, Burn Wounds - Partial Thickness (2nd Degree)
- Being tested
- KJ101, Chymotrypsin, Placebo (Sodium Chloride Injection 0.9%)
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KJ101Drug
- Clean the wound before applying medication.
- Apply KJ101 (800U/mL) to the wound.
- Apply a standard wound dressing after treatment.
- Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days).
ChymotrypsinDrug
- Clean the wound before applying medication.
- Apply Chymotrypsin (800U/mL) to the wound.
- Apply a standard wound dressing after treatment.
- Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days).
Placebo (Sodium Chloride Injection 0.9%)Drug
- Clean the wound before applying medication.
- Apply Placebo (Sodium Chloride Injection 0.9%) to the wound.
- Apply a standard wound dressing after treatment.
- Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days).
| Study group | Role | What they receive |
|---|---|---|
| Experimental-KJ101-Dose Group -1 | Experimental | KJ101 , Dose Group -1 (800 U/mL) Receives: Drug: KJ101 |
| Experimental-KJ101-Dose Group -2 | Experimental | KJ101 , Dose Group -2 (1200 U/mL) Receives: Drug: KJ101 |
| Active comparator | Active comparator | Chymotrypsin (800 U/mL) Receives: Drug: Chymotrypsin |
| Placebo Comparator | Placebo comparator | Placebo Receives: Drug: Placebo (Sodium Chloride Injection 0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Assessing the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) via the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: day 35
Secondary outcomes (10)
The time required for burn wounds to heal completely.
The time taken for the burn wound to reach full epithelialisation, i.e. complete healing.
Measured: day 3 to day 28
Rate of complete healing of burn wounds.
The complete burn wound healing rate was calculated as follows:
(Number of subjects with complete burn wound healing within 28 days of randomisation/Total number of subjects) x 100%.
Complete wound healing of burn wounds in patients was assessed using the criterion of 100% epithelialisation of the burn wound.
Measured: day 28
The time it takes to completely remove necrotic tissue from burn wound.
Necrotic tissue in a wound was defined as inactive tissue that had lost its ability to heal due to irreversible cell death caused by thermal injury. The complete removal of necrotic tissue from a burn wound was defined as the point at which the wound was fully cleared of necrotic tissue, the base was clean, and new tissue had formed.
Measured: day 3 to day 28
Pain intensity evaluation (VAS score)
A visual analogue scale (VAS) is used to assess pain. The basic method involves a 10 cm scale divided into 10 points, with '0' and '10' at each end. '0' represents no pain, while '10' represents the most severe and intolerable pain possible.
Measured: day 1 to day 28
Pharmacokinetics of KJ101 (Cmax)
Maximum observed serum concentration of KJ101 following dosing (Cmax)
Measured: day 28
Pharmacokinetics of KJ101 (AUC)
Area under the serum concentration versustime curve (AUC)
Measured: day 28
Pharmacokinetics of KJ101 (t1/2)
Half-life of KJ101
Measured: day 28
Pharmacokinetics of KJ101 (CL)
Clearance(CL) is a measure of the ability of the body to clear KJ101
Measured: day 28
Pharmacokinetics of KJ101 (Vz)
Vz = Volume of distribution during the elimination phase
Measured: day 28
Immunogenicity
Immunogenicity of KJ101 (Anti-KJ101 antibody) in patients
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start16 Jun 2025 (estimated)
- Primary completion18 Mar 2026 (estimated)
- Study completion29 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025408
- Sponsor's protocol ID
- SHBJ-KJ101-002
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Dose-exploratory, Controlled Drug and Placebo-controlled Phase II Clinical Trial Evaluating the Safety, Efficacy, Pharmacokinetic Profile, and Immunogenicity of KJ101 for Wound Debridement in Deep II Degree Burns
- ClinicalTrials.gov ID
- NCT07025408
- Acronym / sponsor ID
- SHBJ-KJ101-002
- Conditions
- Burn, Burn Wounds - Partial Thickness (2nd Degree)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (estimated)
- Primary completion
- 18 Mar 2026 (estimated)
- Study completion
- 29 Aug 2026 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled Phase II clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of KJ101 for the debridement of deep second-degree burns. The trial will provide supporting evidence for subsequent Phase III trials.
Detailed description
This multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled Phase II clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of KJ101 in the debridement of deep second-degree burns. The aim is to provide supporting evidence for subsequent Phase III clinical trial.
The study comprises four treatment groups: KJ101 at a dose of 800 U/mL; KJ101 at a dose of 1200 U/mL; an active comparator group receiving chymotrypsin at a dose of 800 U/mL; and a placebo control group.
Approximately 144 screened and qualified subjects will be randomised at a ratio of 1:1:1:1 to one of the four groups. All interventions will be administered locally to the target wound at the following frequencies: once daily prior to complete necrotic tissue debridement, and then every other day post-debridement.
Treatment will continue until complete wound healing is achieved (with a maximum treatment duration of 28 days), after which there will be a one-week safety follow-up period will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental-KJ101-Dose Group -1 | Experimental | Drug: KJ101KJ101 , Dose Group -1 (800 U/mL) |
| Experimental-KJ101-Dose Group -2 | Experimental | Drug: KJ101KJ101 , Dose Group -2 (1200 U/mL) |
| Active comparator | Active comparator | Drug: ChymotrypsinChymotrypsin (800 U/mL) |
| Placebo Comparator | Placebo comparator | Drug: Placebo (Sodium Chloride Injection 0.9%)Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects aged 18 to 65 years inclusive, who are neither pregnant nor lactating;
- Clinically diagnosed with superficial or deep II degree burns within 72 hours of injury, with a total burn area of ≤30% TBSA. The target burn wound must be isolated or have distinguishable boundaries, with an area between 40 and 200 cm².
- Subjects of childbearing age must agree to use effective and safe contraceptive methods during the treatment period and for three months after the final administration.
Key exclusion criteria (6 listed)
- Individuals who are known to be allergic to any component of the test drug or who have a tendency to allergies.
- Burns caused by specific factors, such as electrical or chemical burns.
- Subjects with shock or inhalation lung injury;
- Subjects with target wounds complicated by inflammatory skin diseases (e.g. atopic dermatitis, eczema or psoriasis), or who have undergone enzymatic debridement (e.g. with collagenase, papain, bromelain, chymotrypsin or trypsin).
- Subjects who, during screening, are judged by the investigator to have other severe systemic infections requiring systemic treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KJ1011. Clean the wound before applying medication. 2. Apply KJ101 (800U/mL) to the wound. 3. Apply a standard wound dressing after treatment. 4. Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days). | Drug | Experimental-KJ101-Dose Group -1, Experimental-KJ101-Dose Group -2 |
| Chymotrypsin1. Clean the wound before applying medication. 2. Apply Chymotrypsin (800U/mL) to the wound. 3. Apply a standard wound dressing after treatment. 4. Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days). | Drug | Active comparator |
| Placebo (Sodium Chloride Injection 0.9%)1. Clean the wound before applying medication. 2. Apply Placebo (Sodium Chloride Injection 0.9%) to the wound. 3. Apply a standard wound dressing after treatment. 4. Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days). | Drug | Placebo Comparator |
Primary outcome
Adverse events
Time frame: day 35
Assessing the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) via the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
10 secondary outcomes
The time required for burn wounds to heal completely.
Time frame: day 3 to day 28
Rate of complete healing of burn wounds.
Time frame: day 28
The time it takes to completely remove necrotic tissue from burn wound.
Time frame: day 3 to day 28
Pain intensity evaluation (VAS score)
Time frame: day 1 to day 28
Pharmacokinetics of KJ101 (Cmax)
Time frame: day 28
Pharmacokinetics of KJ101 (AUC)
Time frame: day 28
Pharmacokinetics of KJ101 (t1/2)
Time frame: day 28
Pharmacokinetics of KJ101 (CL)
Time frame: day 28
Pharmacokinetics of KJ101 (Vz)
Time frame: day 28
Immunogenicity
Time frame: day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KJ101 and Chymotrypsin in people with Burn and Burn Wounds - Partial Thickness (2nd Degree), run by Shanghai Bao Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.